A loophole in Bioethics rules created by Congress in 1996, will allow EMT's to give you fake blood products without your consent if you are randomly chosen for a research program involving Biopure's PolyHeme blood alternative which is nearing the end of FDA trials.
That's right, people who are in serious accidents are receive aid from EMTs and paramedics working with hospitals like Denver health could be performing an expeirment on you without you even knowing it. The problems with this are mind-boggling and have little to do with the efficacy of PolyHeme, which is derived from hemoglobin.
PolyHeme, to be sure, does have admirable traits: it can be used regardless of blood type, it has a long shelf-life, it won't transmit disease, and it's easy to use. All of these are great advances. It can also be used by Jehova's Witnesses, since their church has decided that it isn't really blood. That's the good side.
The bad side is that human beings, people, will be expiremented on without their knowledge or consent. That's ethically wrong, at the very least, and makes me wonder about Biopure's committment to ethical business practices. this also makes me wonder about their dedication to quality control. If they can't be bothered with informed consent, what else are they willing to skimp on?
At a larger level this particular case is about researchers and physicians who don;t agree that the patient has the ultimate right to participate in their own care and make decisions about their own health. In this respect they set themselves up as God, making your life choices for you.
My wife and I recently had personal experiences with informed consent issues and physicians when she was in the hospital. Her case was minor compared to the idea of receiving experimental artificial blood products without consent. Her doctors merely scheduled x-rays, cat scans, PIC lines, other tests and standard medications without consulting with us first. Little of this would have the serious medical complications that a problem with PolyHeme could in an an emergency situation for a patient who is bleeding.
PolyHeme potentially is a giant step forward for medicine, and it should be widely tested. But it must be done with the knowledge and consent of those who receive it until it is approved by the FDA. Even then, it should be used with the knowledge of the patients with the exception of emergencies. Under no circumstances should PolyHeme, or other experimental treatments, be used on people without their consent.
Posted by Chris at April 6, 2004 03:28 PM